National health authorities and governmental regulatory Agencies in major countries require Pharmaceutical Manufacturers to collect and report Adverse Drug Reactions, Adverse Events, Product Complaints and Device Failure Complaints, and to provide Full Disclosure about the side effects, risks and contraindications associated with their products. Reports of Adverse Events are received by pharmaceutical manufacturers via letter, fax, e-mail or telephone and are usually processed by safety professionals. The process consists of a series of sequential and/or concurrent sub-processes: Intake, Investigation and Follow-up, Analysis and Reporting. The Adverse Event is usually received as a report (Narrative Verbatim) and is then processed by a healthcare professional, entered into a database system, catalogued and linked to a dictionary of international standard medical terminology such as the terms found in MedDRA, the Medical and Drug Regulatory Affairs Code, or other nationally or internationally recognized coding schema such as World Health Organization's Adverse Reactions Terminology (WHO-ART) Dictionary, or the U.S. Food and Drug Administration's (FDA) Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART) schema, either by hand or assisted by a semi-automated processes, called auto-encoding.
The investigation and follow-up sub-processes aim at having the event verified and validated by a healthcare professional (physician, hospital). A judgment is reached, whether the Adverse Event report is serious (according to existing definitions established by a national health authority or drug regulatory agency) and unknown, (unlabeled) in which case a report has to be filed with the health authorities within a short period (usually 15 days). All other cases are regularly analyzed and reported on an annual or semi-annual basis in accordance with the laws, regulations or guidelines set forth by a national health authority or drug regulatory agency.
In cases where the Adverse Event occurred in a foreign country or was received by a license taker of the manufacturer, the reports are transferred between manufacturer's safety organizations, requiring rapid information transfer and rigorous quality assurance measures. Special measures have to be taken in cases where reports or data get translated from one language to another. The aim of the reporting process is to discover previously unknown Adverse Drug Reactions, Drug-Drug Interactions, Drug-Food Interactions or other safety issues at an early stage.
The use of standardized terminology is intended to bring uniformity to the reporting for a large international user base with varied linguistic and cultural differences in reporting Adverse Events and Product Complaints. It is intended as a pragmatic, clinically validated compendium of medical terminology with an emphasis on ease-of-use of data entry, retrieval, analysis and display, with a suitable balance between sensitivity and specificity, within the regulatory environment. A standardized dictionary, such as for example MedDRA is applicable to all phases of development for a drug product and the period during which a drug product is sold, and is also applicable to the product life cycle of most medical devices. By providing one standard of medical terminology, the effectiveness and transparency of medical product regulation worldwide is improved. Standardized terminology for reporting Adverse Events or Product Complaints is grouped in three main associations:                Equivalence: synonymous terms are grouped together.        Hierarchical: provides vertical links between superordinate (broad grouping terms) and subordinate descriptors        Associative: allows terms, which are neither equivalent nor hierarchically related but may be related by sign, symptom, body system or organ class, disease and/or diagnosis to be linked horizontally (Special Search Categories).A standardized dictionary can contain many terms. For example, in the current version of MedDRA at each level is has approximately the following number of terms:        a System Organ Class (SOC)—26        High Level Group Term (HLGT)—334        High Level Term (HLT)—1,663        Preferred Term (PT)—approximately 11,000; International Level of Communication        Lowest Level Term (LLT)—approximately 46,000; Synonyms        
The use of multiple standardized terminologies however in reporting and codifying Adverse Events poses challenges and creates coding requirements with respect to accurately assessing information collected vis-à-vis a single Adverse Drug Reaction or Adverse Event case, or trending information collected across multiple cases albeit for a single drug product or even for similar but not identical drug products that produce the same desired therapeutic effect through similar mechanisms of action within the human body. Because of the large number of terms, there are sometimes too many choices to describe a particular Adverse Event or device complaint. In addition, there are problems due to the fact that each reported event requires a written verbatim narrative of the event, which requires that the safety professional be well versed in the standardized formats and terminologies employed to catalog and characterize various Adverse Events and Product Complaints. Selection of the proper term and creating a highly standardized and structured format applied to each verbatim report are difficult and time-consuming processes requiring great care.
What is desired therefore is a system and method for assisting and rigorously structuring in the intake, investigation and Follow-up, Analysis and Reporting of all Adverse Events and Product Complaints, but especially spontaneously reported cases.
It is also desired to provide a system and method for standardizing Adverse Event and Product Complaint reporting. In that way an untrained health professional or a company employee assigned to receive, process and record. Adverse Event reports or can receive and record event reports without the need for intensive training in safety, safety data and information collection, applying and utilizing various coding schema, or applying and utilizing requisite clinical safety knowledge. In addition, with such a system, a patient can, in a highly effective, efficient and standardized manner, report meaningful safety data and information directly to an interested party such as his/her treating physician or a manufacturer of a drug product.
It is also desired to provide a system and method to efficiently generate Adverse Event and Product Complaint reports in order to comply with event reporting time deadlines.
It is also desired to provide a system and method to efficiently, safely and seamlessly transfer the collected data into any standard industry drug safety system, using industry standard protocols and definitions like the E2B and E2C standards defined by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH M1-3).
It is also desired to provide a system and method to collect and manage data utilizing a network computer system operating in a stateless environment, while having the ability to maintain and manage state.